Overview

Lurtotecan Liposome in Treating Patients With Advanced Solid Tumors

Status:
Completed
Trial end date:
2008-09-22
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of lurtotecan liposome in treating patients who have advanced solid tumors.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
NCIC Clinical Trials Group
Collaborator:
Nexstar Pharmaceuticals
Treatments:
Lurtotecan
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced solid tumors
that are unresponsive to existing therapy and for which no curative therapy exists Evidence
of disease other than tumor marker elevation No untreated CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST and ALT no
greater than 2.5 times ULN (no greater than 5 times ULN for liver metastases) Renal:
Creatinine no greater than upper limit of normal Cardiovascular: Not specified Pulmonary:
Not specified Other: No prior malignancy within past 5 years except curatively treated
basal or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or
nursing Fertile patients must use effective contraception No active or uncontrolled
infection No other serious illness or medical condition No known hypersensitivity to
systemic liposomal formulation or any drug chemically related to study drug

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No greater than 3
prior chemotherapy regimens (adjuvant and metastatic) At least 3 weeks since prior adjuvant
and metastatic chemotherapy (6 weeks for nitrosoureas or mitomycin and 4 weeks for
carboplatin or other experimental anti cancer drugs) and recovered At least 1 year since
prior high dose chemotherapy with bone marrow or stem cell support No other concurrent
chemotherapy Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal
therapy Radiotherapy: No prior radiotherapy to greater than 25% of bone marrow At least 4
weeks since prior radiotherapy, except for low dose myelosupressive radiotherapy, and
recovered Concurrent palliative radiotherapy allowed Surgery: Not specified Other: At least
4 weeks since prior experimental drug or anticancer therapy No other concurrent
investigational or anticancer therapy